Table 4. Projected number of study participants required for future clinical trial (single site).
Two Independent Groups | ||||||
MRI Measure | 80% Power | 90% Power | ||||
5% Difference | 10% Difference | 20% Difference | 5% Difference | 10% Difference | 20% Difference | |
Volume [ml] | 2142 | 538 | 136 | 2868 | 718 | 182 |
PVI [ml/kg] | 768 | 198 | 50 | 1026 | 264 | 68 |
ADC [mm2/s] | 258 | 128 | 16 | 346 | 170 | 20 |
MTR | 722 | 182 | 46 | 964 | 242 | 60 |
Within Subject Variation | ||||||
MRI Measure | 80% Power | 90% Power | ||||
5% Difference | 10% Difference | 20% Difference | 5% Difference | 10% Difference | 20% Difference | |
Volume [ml] | 40 | 12 | 5 | 53 | 15 | 5 |
PVI [ml/kg] | 36 | 11 | 4 | 48 | 14 | 5 |
ADC [mm2/s] | 18 | 10 | 3 | 23 | 13 | 3 |
MTR | 128 | 16 | 6 | 170 | 21 | 7 |